Fast Facts: Biosimilars

By P. Cornes and D.J. Bennett

Biosimilars have been in clinical use for more than 10 years, and evidence from more than 700 million patient-days’ exposure shows that approved biosimilars can be used as safely and effectively as their originator biologics. And yet concerns about these drugs persist, particularly in therapy areas where they are recent additions to the formulary. It is vital to address these concerns so that clinicians can prescribe biosimilars with confidence, realizing substantial cost savings and improving patient access to effective treatments. 'Fast Facts: Biosimilars' provides a comprehensive yet concise explanation of biosimilars: what they are, how they are regulated, and how they are used in clinical practice. It is ideal for healthcare professionals and decision makers who want to understand biosimilars and the key concerns and controversies around these valuable products. Contents: 1 - An introduction to biologics and biosimilars 2 - Why do we need biosimilars? 3 - How is the quality of biosimilars assured? 4 - How is the efficacy and safety of biosimilars ensured? 5 - What has been the experience with biosimilars to date? 6 - The future of biosimilar medicines 7 - How do I use biosimilar medicines?

• Language: English
• Publisher: S. Karger
• Release date: Apr 9, 2018
• ISBN: 9781910797686

Book preview

Introduction

Biologics have revolutionized the treatment of many serious disorders, and continue to do so. The first biologics have now reached patent expiry and lower-cost versions – biosimilar medicines – have been developed. The evidence acquired over 10 years of clinical experience, from 30 biosimilar drugs and more than 700 million patient-days’ exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. The potential cost savings that can be realized through the use of biosimilars is putting pressure on clinicians to prescribe these biosimilars in preference to the originator biologic. The use of biosimilars has the potential to increase patient access to effective treatments; however, concerns persist about biosimilars, particularly in therapy areas where biosimilars are relatively recent additions to the formulary.

Fast Facts: Biosimilars addresses these concerns, drawing on the most up-to-date information in this fast-moving area of medicine:

• Is the quality of the biosimilar medicine equivalent to that of the original drug?

• Is the biosimilar medicine safe?

• Which indications can the biosimilar medicine be used for?

• What are the realistic economic benefits?

• How do I switch a patient from a biologic to an equivalent biosimilar medicine?

The answers are supported with a concise explanation of the underlying science and regulatory principles, drawing on the significant experience accumulated within Europe, together with emerging global practice.

This concise authoritative resource will help clinicians and other healthcare decision makers to determine the value of biosimilars in clinical practice and aid discussions with patients.

Terminology is a key issue in the field of biologics and biosimilars, with terms often used incorrectly, causing confusion (see page 12 for examples). Definitions of these terms are provided in Table 1.1.

Biologics

Biologics are large macromolecules, typically proteins. They range in size and structural complexity from simple proteins such as insulin and growth hormone to complex molecules such as coagulation factors and monoclonal antibodies, as shown in Figure 1.1. Many biologics, particularly the monoclonal antibodies, are described as targeted therapies because they have been designed to interact with specific receptors on cells.

Biologics are created in living systems, such as bacterial, animal or human cell cultures, or are extracted from whole organisms; they cannot be synthesized chemically. Most biologics are complex mixtures; whilst their primary and secondary structures are known, they are less easily characterized at the tertiary level. This stands in contrast to conventional ‘small molecule’ drugs, which usually have a unique structure that can be fully characterized and are typically produced by inexpensive chemical synthesis that is straightforward to replicate. The complex nature of the biologics, and their manufacturing processes, means that identical copies of these molecule cannot be created.

Figure 1.1 Examples of the varying complexity of biologics¹

Biosimilar medicines

A biosimilar, as its name suggests, is highly similar to the reference biologic product, but is not identical. The primary and secondary amino acid structure, dosing, and route of administration are the same; differences in formulation, presentation, and the administration device are permitted, provided that these differences do not affect safety or effectiveness. As with all biologic medicines, the challenge for manufacturers and regulators is to ensure that copies of biologics are close enough in structure and function to the reference product to have no clinically meaningful differences in practical